11 March 2015
World Health Organisation – Prequalification Team
Prequalification of Active Pharmaceutical Ingredients (APIs)
Application form
Please complete each section of this application form electronically. Please ensure an electronic
and printed version of this application form accompanies your submission for API
prequalification.
1. Application details
Active pharmaceutical ingredient (INN)
Agent's name (if applicable)1
Applicant company (if applicable) 1
API Manufacturing site(s) address
API Intermediate Manufacturing site(s)
address
(include intermediate name)
Contact person responsible for this
application
Title:
First name:
Last Name:
Contact person's job title
Contact person's postal address
Contact person's email address
Contact person's phone number
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
1
If an agent is making this application on behalf of the manufacturer then a relevant letter of
authorization from the API manufacturer should be attached to this application form.
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
2 Active Pharmaceutical Ingredient Master File (APIMF)
The submitted APIMF has been assigned the following API manufacturer's version number:
Open part:
___________________________________
Closed Part:
___________________________________
(Please select one option below only and delete the remaining options)
OPTION 1
The active pharmaceutical ingredient master file (APIMF) included with this application has not
previously been submitted to the WHO Prequalification of Medicines Programme.
OPTION 2
No active pharmaceutical ingredient master file (APIMF) is included with this application. In
support of this application reference should be made to APIMF_________ (WHO APIMF number),
which is currently accepted by the Prequalification of Medicines Programme.
The currently submitted APIMF meets the documentation requirements specified on the
Prequalification Programme’s website.
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
3. Other information
If the APIMF document (current version) is currently lodged with another Medicine Regulatory
Agencies please list these:
Agency
Date of submission
Agency code (if applicable)
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
4. Site Master File
(Please select one option only and delete the remaining options)
Option 1
1. The site master file (SMF) included with this application has not previously been submitted to
the WHO Prequalification of Medicines Programme.
2. The (SMF) has the assigned company version number:
___________________________________________________
(State the version number of SMF)
Option 2
1. The site master file (SMF) included with this application is an updated version of the SMF
previously submitted to the WHO Prequalification of Medicines Programme. The previously
submitted SMF has the version number __________________________.(version number of
previously submitted SMF).
The submitted site master file replaces the site master file (SMF) currently held by WHO.
2. The submitted site master file (SMF) has the assigned company version number:
___________________________________________________
(State the version number of SMF)
Option 3
1. No site master file (SMF) has been included with this application. Reference should be made
to the SMF previously submitted to WHO Prequalification of Medicines Programme in
correspondence dated __________________ (date of previous submission).
2. The previously submitted site master file (SMF) has the assigned company version number:
___________________________________________________
(State the version number of SMF)
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
5. Evidence of compliance with Good Manufacturing Practices (GMP)
5.1 Inspection declarations
(Please select one option only and delete the remaining options)
Option 1
To establish that the indicated site(s) of API manufacture are operating in compliance with
GMP, ____________ (company name) requests that WHO arranges to inspect this/these
facility(ies).
Name:
___________________________________
Signature:
___________________________________
Date:______________
Option 2
To demonstrate that the indicated site(s) of API manufacture are operating in compliance with
GMP, evidence of this compliance has been included with this application. Nonetheless,
____________ (company name) acknowledges that WHO may need to inspect this/these
facility(ies).
Name:
___________________________________
Signature:
___________________________________
Date:______________
4.2 A summary of the evidence of compliance with GMP submitted with application:
(If supporting documentation has been provided, please summarise briefly below)
Type of document
Issuing authority
Date of issue
Remark
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
5. Declaration
I, the undersigned, on behalf of _________________________ (company name) declare that the
information contained in this application form and in the submitted documents is accurate. I
confirm that information in the application form and the submitted documents does not contain
intentionally misleading information, nor has information been withheld that might affect the
assessment of compliance with WHO requirements. I confirm that the submitted APIMF meets
the documentation requirements specified on the Prequalification Programme’s website. I
confirm that WHO PQT may undertake an on-site inspection at any time, either announced or
unannounced, to confirm that the API manufacturing site, and or any associated intermediate,
testing or contract manufacturing site, is manufacturing in compliance with WHO GMP
standards.
Name:
___________________________________
Signature:
___________________________________
Position within company:
Date:______________
_________________________________________
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015
6. Application Checklist
To ensure a complete application, please use this checklist to verify that all required information
has been prepared for submission on a single CD or DVD.
Item
Submitted
(Yes / Not applicable)
1. A cover letter (paper copy)
2. A single well labelled CD or DVD containing:

the cover letter (Word or text selectable PDF)

the API Prequalification application form (Word)
AND

the signed API Prequalification application form (PDF)

the APIMF correctly formatted (Module 3, see
documentation requirements section)

the Module 2 Quality overall Summary

the site master file (SMF) for each manufacturing site
(Word or text selectable PDF)

evidence of compliance with Good Manufacturing
Practices (GMP), or a request for inspection by WHO for
each manufacturing site (Word or text selectable PDF)
The cover letter and CD/DVD should be sent to:
World Health Organization
WHO Prequalification Team - Medicines
HIS/EMP/RHT Room 613
20 Avenue Appia
1211 Geneva 27
Switzerland
Application for Prequalification of Active Pharmaceutical Ingredients – 11 March 2015